Status:
UNKNOWN
Intravenous Fluids in Pediatric Migraine
Lead Sponsor:
Dayton Children's Hospital
Conditions:
Migraine
Migraine in Children
Eligibility:
All Genders
5-21 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are: * Does a large amount of fluids (bolus) improve pa...
Detailed Description
Patients will be randomized to one of two treatment groups. The intervention group will receive a 20 mL/kg bolus of normal saline (with a maximum of 1L), given over one hour. The control group will r...
Eligibility Criteria
Inclusion
- At least 1 prior headache
- Minimum pain score of 10mm
- Headache lasting 2-72 hours
- At least two of the following four: 1 Bifrontal/bitemporal or unilateral location, 2 Pulsating quality, 3 Moderate or severe pain intensity, 4 Aggravation by or causing avoidance of routine physical activity
- At least one of the following: 1 Nausea and/or vomiting, 2Photophobia and phonophobia, 3 Not better accounted for by another ICHD-3 diagnosis
Exclusion
- Shunted hydrocephalus
- Temperature equal to or greater than 38.5C
- Clinical suspicion of meningitis
- Known or suspected intracranial lesion
- Clinical evidence of significant dehydration (or signs of shock, or attending discretion)
- Head trauma in previous 7 days
- Pregnancy or breastfeeding
- Initial pain score less than 10mm
- Allergy to study medications
- Patients previously participating in the study
Key Trial Info
Start Date :
June 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06182098
Start Date
June 27 2023
End Date
June 1 2025
Last Update
December 26 2023
Active Locations (1)
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1
Dayton Children's Hosptial
Dayton, Ohio, United States, 45404